Hand Function for Tetraplegia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00890916
First received: April 27, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.


Condition Intervention Phase
Spinal Cord Injury
Tetraplegia
Device: FIRSTHAND System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hand Function for Tetraplegia Using a Wireless Neuroprosthesis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Grasp Release Test - test of functional ability to pick up and move objects [ Time Frame: 6-9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Receives implanted device for hand function.
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.

Detailed Description:

The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system known as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cervical level spinal cord injury;
  • complete paralysis of fingers and thumbs;
  • voluntary shoulder motion;
  • electrically excitable forearm and hand musculature

Exclusion Criteria:

  • extreme contractures of the joints;
  • skeletal immaturity;
  • extensive denervation in the forearm and hand;
  • poor surgical risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890916

Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin L. Kilgore, PhD VA Medical Center, Cleveland
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00890916     History of Changes
Other Study ID Numbers: A6027-R
Study First Received: April 27, 2009
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
spinal cord injury
neuroprosthesis
functional electrical stimulation
quadriplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014